Nilotinib (Nilonix) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.
Nilotinib is used to treat a type of blood cancer called Philadelphia chromosome positive chronic
myeloid leukemia (CML) in adults and children who are at least 1 year old. Nilotinib is usually given
after other medications have been tried without success. PRESCRIBING INFO PRODUCT VERIFY USER GUIDE
To avoid counterfit medicine,Please flow the Verification Guide
Nilonix 150 : Each capsule contains 150 mg nilotinib as hydrochloride monohydrate. Nilonix 200 : Each capsule contains 200 mg nilotinib as hydrochloride monohydrate.
INDICATIONS
Newly diagnosed Ph+ CML-CP
Nilotinib is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The effectiveness of Nilotinib is based on major molecular response and cytogenetic response rates.
Resistant or intolerant Ph+ CML-CP and CML-AP
Nilotinib is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) in adult patients resistant or intolerant to prior therapy that included imatinib. The effectiveness of Nilotinib is based on hematologic and cytogenetic response rates.
DOSAGE
Recommended Dosing
Nilonix should be taken twice daily at approximately 12-hour intervals and must be taken on an empty stomach. No food should be consumed for at least 2 hours before the dose is taken and for at least 1 hour after the dose is taken. Advise patients to swallow the capsules whole with water.
For patients who are unable to swallow capsules, the contents of each capsule may be dispersed in 1 teaspoon of applesauce (puréed apple). The mixture should be taken immediately (within 15 minutes) and should not be stored for future use.
Resistant or intolerant Ph+ CML-CP and CML-AP
Nilotinib is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) in adult patients resistant or intolerant to prior therapy that included imatinib. The effectiveness of Nilotinib is based on hematologic and cytogenetic response rates.
Nilonix may be given in combination with hematopoietic growth factors such as erythropoietin or G-CSF if clinically indicated. Nilonix may be given with hydroxyurea or anagrelide if clinically indicated.
Dosage in Newly Diagnosed Ph+ CML-CP
The recommended dose of Nilonix is 300 mg orally twice daily.
Dosage in Resistant or Intolerant Ph+ CML-CP and CML-AP
The recommended dose of Nilonix (nilotinib) is 400 mg orally twice daily.
MANUFACTURER
Facilities
Beacon Pharmaceuticals Limited has the world class facilities to manufacture world class products. The state-of-the-art facilities of Beacon is designed & developed by the renowned European Consultant Company to meet the highest international regulatory standards like US-FDA, UK-MHRA, TGA-Australia.
The facility is located at Bhaluka, Mymensingh, 79 km North from Dhaka, Capital city of Bangladesh. The total area of the site is 60703 square meter (15 acres) with a built up area of 15000 square meter. The buildings are Ferroconcrete structure & equipped with all the Hi-Tech sophisticated production machineries.
Quality Policy
When you buy our products, you can be sure of their quality, safety and efficacy.
To this end, the Company has set up, implemented and continuously improves the pharmaceutical quality management system in compliance with the regulatory requirements in force and the worldwide standards.
The system is intended to provide and constantly maintain the proper quality level of products and compliance with the requirements of the current good practices.
Beacon At A Glance
CSR
When you buy our products, you can be sure of their quality, safety and efficacy.
To this end, the Company has set up, implemented and continuously improves the pharmaceutical quality management system in compliance with the regulatory requirements in force and the worldwide standards.
The system is intended to provide and constantly maintain the proper quality level of products and compliance with the requirements of the current good practices.